MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC KNEE COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-012-44-4015
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Noise, Audible (3273); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Arthrofibrosis (4885)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, that the 62 yo male patient experienced arthrofibrosis and patellar clunk resulting in painful catching and clicking in the l knee.The date of adverse event onset is (b)(6) 2017.The patient was treated with physical therapy and bracing.The patient¿s outcome was last known as resolved on (b)(6) 2018.
Additional Manufacturer Narrative
Concomitants: 06001016009, a10012 - gps implant kit v2; serial #: (b)(4), category #: 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; serial #: (b)(4), category #: 208-06-04 - cc distal fem augment sz 4, 10mm; serial #: (b)(4), category #: 02-012-60-2080 - logic stem ext 20mm x 80mm; serial #: (b)(4), category #: 02-010-06-0541 - logic post.Aug.Block size 4, 5mm; serial #: (b)(4), category #: 02-010-06-0541 - logic post.Aug.Block size 4, 5mm; serial #: (b)(4), category #: 204-70-00 - tibial stem ext.Screw; serial #: (b)(4), category #: 208-06-04 - cc distal fem augment sz 4, 10mm; serial #: (b)(4), category #: 02-010-06-0240 - logic cc femoral size 4, left; serial #: (b)(4), category #: 02-012-61-2000 - logic offset stem ext coupler 2mm; serial #: (b)(4), category #: 02-012-60-1440 - logic stem ext 14mm x 40mm; serial #: (b)(4), category #: 02-012-66-2000 - metaphyseal tibial cone, ml32mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6, h11 the following sections were corrected: b3, d1, d4, g4, h4, h6.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The patient has lupus which is a cause of ligament and joint maladies.These devices are used for treatment not diagnosis.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK LOGIC KNEE COMPONENTS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16599755
• Report Number: 1038671-2023-00493
• Device Sequence Number: 7325301
• Product Code: JWH
• UDI-Device Identifier: 10885862173669
• UDI-Public: 10885862173669
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2020
• Device Catalogue Number: 02-012-44-4015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 100 KG